Glaxo's Partner Begins Phase I Study on Coronavirus Vaccine

GlaxoSmithKline plc GSK announced that its China-based partner Clover Biopharmaceuticals has initiated a phase I study to develop a COVID-19 vaccine candidate using Glaxo’s pandemic vaccine adjuvant technology.

The research collaboration with Clover Biopharmaceuticals to make COVID-19 S-Trimer vaccine (SCB-2019) vaccine candidate was announced by Glaxo in February. Preliminary data from the phase I study is expected in August while a phase IIb/III vaccine efficacy study is expected to be initiated later this year. Clover signed a similar deal with Dynavax Technologies Corporation DVAX under which the latter is providing its CpG 1018, the adjuvant contained in its marketed hepatitis B vaccine, to enhance the immune response of Clover’s COVID-19 vaccine.

Glaxo has formed several collaborations to make its pandemic adjuvant technology available to partners, including with scientific partners in North America, Europe and China, who are making adjuvanted COVID-19 vaccine candidates. The pandemic adjuvant can reduce the amount of vaccine protein required per dose, which, in turn, will allow more vaccine doses to be produced. It can also increase the immune response of vaccines, thereby providing better immunity. Glaxo has collaborated with Sanofi SNY to combine their innovative technologies to develop an adjuvanted COVID-19 vaccine. The vaccine candidate is expected to enter clinical studies in the second half of 2020.

Glaxo announced last month that it plans to produce 1 billion doses of its pandemic vaccine adjuvant in 2021 that can be used for the development of COVID-19 vaccine candidates that are suitable for use with an adjuvant. Glaxo has decided to enhance its manufacturing capacity at sites in Europe and North America, which will allow it to make 1 billion doses of the adjuvant. Glaxo is in discussion with several governments and global institutions to fund its development of the adjuvant.

So far this year, Glaxo’s shares have declined 12.5% against the industry’s 1.8% increase.

 

 

Glaxo is making several efforts to develop vaccines, antibodies and drugs to combat COVID-19, which has infected more than 9.0 million and killed more than 4,70,000 people globally.

In April, Glaxo signed an agreement with Vir Biotechnology VIR to develop antibody treatments for coronaviruses including SARS-CoV-2, the virus that causes COVID-19. In addition, Glaxo said it will make an equity investment of $250 million in Vir’s stock to gain rights to the latter’s unique antibody platform technology.

In a separate press release Glaxo announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) committee will review its biologics license application (BLA) seeking approval for its pipeline candidate belantamab mafodotin in patients with heavily pre-treated multiple myeloma. The ODAC meeting will be conducted virtually on Jul 14. The BLA is under priority review with the FDA and is based on data from the pivotal DREAMM-2 study.

Glaxo currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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